Kornimate/medical-research-clean huggingface dataset:
intrathecal therapy with monoclonal antibodies in progressive multiple sclerosis

Conditions: Progressive Multiple Sclerosis

Summary: this is a is a small scale open phase two interventional study to assess long-term stabilising effects of on neurological symptoms by regular intrathecal administered monoclonal antibodies in progressive multiple sclerosis.

there is presently no efficient therapy available in progressive ms, especially if there is no clear evidence of active inflammatory lesions or exacerbations as part of the disease. there are, however, evidence that some treatment protocols using cytotoxic drugs may to some extent slow down the progressive course. one specific feature of long-standing ms is that inflammatory cells accumulate in the central nervous system(cns) compartment in the subarachnoid and perivascular spaces and may therefore be hard to reach via standard drug delivery through systemic administration. administration of substances via the intrathecal (it) route, however, have shown to efficiently distribute in the subarachnoid spaces and may therefore be an attractive route of drug delivery

Eligibility criteria:
inclusion criteria: * between the age of 18 and 65 years of age (nonfertile women or fertile women with effective contraceptive methods) * progressive ms since at least three years * some kind of documented progression of neurological symptoms during the previous two years. * expanded disability status scale (edss) 4,0 - 7.0 (inclusive) (basically spared arm functions) * conventional therapy not indicated, contraindicated or failed * judged as compliant with the protocol exclusion criteria: * eligible for any of the conventional ms therapies * relapsing remitting multiple sclerosis (rrms) * bleeding diathesis or medication contraindicating neurosurgical procedures or lumbar puncture * cognitive defect making informed consent unreliable * any medical condition contraindicating minor surgical procedures, as judged by anaesthesiologist * severe, uncontrolled heart disease * pregnant or lactating women * patients having contraindication for or otherwise not compliant with mri investigations * documented vulnerability to infections * simultaneous treatment with other immunosuppressive drugs * documented allergy or intolerance to rituximab * severe psychiatric condition

Keywords: progressive multiple sclerosis monoclonal antibodies mabthera intrathecal treatment
immediate fever during anaesthesia recovery after surgical procedure with scoliosis

Conditions: Fever; Scoliosis; Surgical Trauma; Hypothermia; General Anaesthesia

Summary: fever is a common clinical symptom in patients with postoperative scoliosis. however, there are rare reports of immediately fevers occurring following operative procedures.

postoperative fever is a common clinical symptom in patients following spinal surgery, with an incidence of 13.2%, and 64.5% of patients with neuromuscular scoliosis were observed to develop postoperative fevers. the most frequently observed cause of fever is surgical trauma, which is associated with inflammatory responses to surgery, and such fevers typically resolve within 2-3 days. this self-limited cause of postoperative fever is non-pathological,4 and the severity and duration of such fevers depend on the duration, scope, and type of surgery, and whether a mesh graft was inserted. the aetiology of immediate postoperative fever for patients following hip prosthesis implantation is unknown, and it is inexpedient to initiate antibiotic treatment or to increase the prophylactic antibiotic dosage. however, there are rare reports of chills and fevers occurring immediately following spinal surgery, to the best of our knowledge, there have been no reports on the mechanism of immediate postoperative fever following spinal surgery. based on this evidence and on observation, when patients experience postoperative fevers, nearly all surgeons seek to exclude infection as a cause. the case presented in this paper is that of a 15-year-old female with idiopathic scoliosis who underwent posterior idiopathic scoliosis incision and correction for pedicle fixation. the clinical symptoms of interest, including chills, a high fever, an increased heart rate and increased blood pressure, were observed immediately during the course of anaesthesia resuscitation. in this report, risk factors, treatment and prevention are assessed based on the case evidence.

Eligibility criteria:
inclusion criteria: * n/a exclusion criteria: * n/a
caspar : clopidogrel and acetyl salicylic acid in bypass surgery for peripheral arterial disease

Conditions: Arterial Occlusive Diseases

Summary: primary objective: to evaluate whether clopidogrel 75 mg o.d. versus placebo (on a background of asa 75-100 mg/d) will lead to an increased rate of primary patency, limb salvage and survival, in patients receiving a below knee bypass graft for the treatment of pad. secondary objectives: comparison, between the two treatment groups, of : * primary patency, * assisted primary patency, * cardiovascular death / myocardial infarction / stroke / any amputation above the ankle. * ankle brachial pressure index (abpi) changes from baseline


Eligibility criteria:
inclusion criteria: a patient is eligible for inclusion in the study 2-4 days after surgery if all the following criteria are fulfilled: * informed consent obtained; * chronic background treatment with daily asa, whatever the dose, started at least 4 weeks before surgery. a window of a few days without asa before surgery is acceptable, according to local practice. post-randomization use of asa must be between 75 and 100 mg/day. * unilateral below knee bypass graft (i.e. the distal anastomosis is below the level of the knee joint) for atherosclerotic pad within the previous 4 days; * demonstration of initial patency of the index graft by an objective measurement (e.g. intra-operative doppler scanning, flow measurement, angiography, duplex scanning) during bypass surgery, or between surgery and the time of randomization; * no clinical evidence of graft occlusion at time of randomization. exclusion criteria : pad medical/surgical history * onset of pad symptoms before the age of 40 years * non-atherosclerotic vascular disease (e.g. buerger's disease, popliteal entrapment syndrome) * patient receiving aorto-bifemoral, iliac-femoral or crossover (femoral-femoral) grafts, or undergoing peripheral transcutaneous angioplasty (pta), with or without stenting, during the same surgery. medical history related to bleeding risk * current active bleeding at surgical site * withdrawal of an epidural catheter less than 12 hours before randomization * current active bleeding or increased risk of bleeding, such as severe hepatic insufficiency, proliferative diabetic retinopathy, peptic ulceration, bleeding diathesis or coagulopathy * peptic ulceration within 12 months of randomization * previous or current intracranial hemorrhage or hemorrhagic stroke, or any previous stroke for which the diagnosis of hemorrhagic stroke cannot be excluded * any history of severe spontaneous bleeding such as gastrointestinal bleeding, gross hematuria, intraocular bleeding other medical conditions * previous disabling stroke (severe cerebral deficit such that the patient is bedridden or demented) * nyha class iv heart failure * uncontrolled hypertension: systolic blood pressure (sbp) \> 180 mm hg, or diastolic blood pressure (dbp) \> 100 mm hg
bare -metal stents and drug -eluting stents in the treatment of patients with vertebral artery ostium stenosis

Conditions: Ischemic Stroke

Summary: the study hypothesizes that drug -eluting stents are more effective in preventing restenosis than bare-metal stents after vertebral artery ostium stenting

the vertebral artery ostium stenosis was one of the higher risk of the ischemia stroke in china. in the mean time ,more and more people accept revascularization. there are no prospective studies for comparison of prevention of restenosis after drug -eluting stents and bare-metal stents until now. the main aim of this study is to observe the following details: 1. late loss in lumen diameter in follow-up ≥50% 2. death, non -fatal stroke 30 days after stent implantation associated with antiplatelet drugs 3. death, non -fatal stroke 12 months after stent implantation associated with antiplatelet drugs secondary endpoint: brain, gastrointestinal and urinary system bleeding in 12 months follow-up

Eligibility criteria:
inclusion criteria: - symptomatic posterior circulation ischemia including monor stroke (mrs ≤2) or tia result from the stenosis in the vertebral artery ostium. 70% to 99% stenosis of vertebral artery ostium. exclusion criteria: * etiology of stenotic lesions not atherosclerosis patients had undergone previos interventions on the vertebral artery ostium ipsilateral severe stenotic lesions in subclavian artery involved as well as vertebral artery ostium

Keywords: ischemic stroke, restenosis,bare-metal stents, drug -eluting stents
injectable platelet rich fibrin with collagen matrix in treatment of multiple gingival recession.

Conditions: Gingival Diseases; Traumatic Injury

Summary: this study is proposing the use of i-prf clot as a scaffold for the xcm in order to obtain a novel biomaterial, incorporating active growth factors and collagen matrix in a single framework, based on the potential effect of i-prf to enhance fibroblast activity and angiogenesis stimulation for treatment of multiple gingival recession.


Eligibility criteria:
inclusion criteria: * presence of at least two localized gingival recessions on either sides of the maxilla and/or mandible excluding molar region. * the cemento-enamel junction (cej) is visible in the teeth for root coverage procedures. * all recessions are type 1recession rt1 (cairo et al,2011) which correspond to miller i\&ii gingival recession * all patients must demonstrate adequate plaque control with a fullmouth plaque score less than 20% and with . * all patients at least 18 years of age and of both genders. exclusion criteria: * smoker patients . * patients with diabetes. * patients with a history of malignancy, radiotherapy, or chemotherapy for malignancy. * pregnant or nursing women. * patients taking medications or having treatments with an effect on mucosal healing in general (e.g. steroids, large doses of antiinflammatory drugs). * patients with a disease affecting connective tissue metabolism. * patients allergic to collagen.

Keywords: gingival recession collagen matrix plasma rich proten
platelet bioenergetics in tbi

Conditions: Brain Injuries, Traumatic

Summary: this is a prospective study enrolling 5 patients with a diagnosis of traumatic brain injury (tbi) without polytrauma and 5 patients with tbi with polytrauma admitted to the university of kentucky (uk) chandler medical center to evaluate differences in platelet bioenergetics in the populations. additionally, five healthy subjects will be recruited to the control group.

traumatic brain injury (tbi) is used to describe a myriad of primary and secondary brain-related injuries related to trauma. clinically, moderate-to-severe brain injury results in early coagulopathy, with a tendency toward unanticipated bleeding, followed by delayed hypercoagulation, with a tendency toward unanticipated clot formation. optimal platelet count, activation and function are necessary for normal coagulation. investigators have recently developed a novel approach to measure platelet activity. this approach specifically measures platelet energy output or bioenergetics from blood samples. preclinical (animal) studies show that platelet bioenergetic profiles are different after tbi and that they change over time. this temporal profile may be used as a biomarker that can inform diagnosis and prognosis of tbi.

Eligibility criteria:
inclusion criteria: * patients must have moderate to severe traumatic brain injury (glasgow coma scale (gcs) 3-13) to be enrolled in the tbi or tbi with trauma groups. * patients enrolled in the tbi with polytrauma group must also exhibit polytrauma including concomitant traumatic brain injury, major trauma to the chest, abdomen, pelvis or extremities. * patients must be greater than or equal to 18 years of age and must be less than or equal to 50 years of age. * patients must be able to cooperate for a detailed neurologic exam. * patients must be consented and undergo first blood sampling within the first 12 hours (+/- 2 hours) after their traumatic brain injury to be enrolled in the tbi or tbi with trauma groups. * patients must be expected to survive to discharge, as assessed by their admitting neurosurgery team exclusion criteria: * for the control group only, patients who have experienced a tbi in the last 6 months. * diagnosis of platelet diseases or disorders, such as thrombocytopenia, thrombocytosis, or von willebrand disease. * platelet transfusion within the last six months. * comorbid regimen of metformin within the last 6 months.

Keywords: tbi
open-label study of oto-201 in pediatric subjects with a history of otitis media requiring tympanostomy tubes

Conditions: Otitis Media

Summary: this is an 8-week, multicenter, open-label study in which eligible subjects with a history of otitis media requiring tt placement will receive 6 mg oto-201 to each ear. the study is designed to evaluate the safety and efficacy of oto-201 in subjects undergoing tt placement with common concurrent surgeries and any middle ear effusion status.


Eligibility criteria:
inclusion criteria includes, but is not limited to: * subject is a male or female aged 6 months to 17 years, inclusive * subject has a history of otitis media requiring bilateral tympanostomy tube placement * subject's caregiver is willing to comply with the protocol and attend all study visits exclusion criteria includes, but is not limited to: * subject has a history of prior ear or mastoid surgery, not including myringotomy or myringotomy with tt placement * subject has been designated for any other surgical procedure that would occur concurrently with tt placement, except adenoidectomy, airway endoscopy, nasal endoscopy, and nasal cautery for epistaxis * subject has a history of sensorineural hearing loss

Keywords: otitis media ear infection tympanostomy tubes
characteristics of post-traumatic stress disorder (ptsd) and non-ptsd subjects

Conditions: PTSD

Summary: compare ptsd and non-ptsd subjects on several demographic, cognitive and military variables


Eligibility criteria:
inclusion criteria: * subjects applied for treatment in the moh rehabilitation centers or the idf unit for combat reactions and were diagnosed with ptsd exclusion criteria: -
investigational imaging technique during brain surgery

Conditions: Astrocytoma; Glioblastoma; Oligodendroglioma

Summary: this early phase i trial tests the safety and reliability of an investigational imaging technique called quantitative oblique back illumination microscopy (qobm) during brain surgery for detecting brain tumors and brain tumor margins in patients with glioblastoma, astrocytoma, or oligodendroglioma. surgical margins refer to the edge or border of the tissue removed in cancer surgery. qobm may be able to assess and reveal brain tumor surgical margins in a more safe and reliable manner.

primary objective: i. to perform a first-in-human study to assess the ability of a quantitative oblique back illumination microscopy (qobm) handheld device to safely and reliably image brain tumor pathology intraoperatively in-situ and in-vivo. secondary objectives: i. to characterize the biophysical and structural features that enable detection of bulk tumor and tumor margins, including infiltrative disease, with qobm. ii. to develop qobm imaging probes with multimodal capabilities (analog black and white and color imaging, fluorescent imaging) and with the potential to clearly reveal brain tumor margins ex vivo and in vivo during neurosurgical procedures. outline: patients undergo craniotomy with intraoperative ex vivo and in situ tumor assessment with qobm. patients then undergo postoperative exam with computed tomography (ct) or magnetic resonance imaging (mri) any of days 1-5 after surgery.

Eligibility criteria:
inclusion criteria: * age \>= 18 years * craniotomy is indicated for tumor management * surgery planned for 14 or fewer days from enrollment * evidence of a personally signed informed consent indicating that the subject is aware of the neoplastic nature of the disease and has been informed of the procedures to be followed, the experimental nature of the device evaluation, alternatives, potential risks and discomforts, potential benefits, and other pertinent aspects of study participation. * a newly discovered brain lesion requiring surgery who imaging is consistent with a new glioblastoma, astrocytoma, or oligodendroglioma or with a progressive histologically proven glioblastoma, astrocytoma, or oligodendroglioma whose management required surgery. exclusion criteria: an individual who meets any of the following criteria will be excluded from participation in this study: * patients who are undergoing needle biopsy only * uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
phase 2/3 open-label trial of sibeprenlimab in the treatment of immunoglobulin a nephropathy

Conditions: Immunoglobulin A Nephropathy

Summary: this is a phase 2/3 open-label trial to evaluate the long-term safety, tolerability, and efficacy of sibeprenlimab administered subcutaneously (sc) in subjects with igan.

this is a phase 2/3, multicenter, open-label trial to evaluate the long-term safety, tolerability, and efficacy of sibeprenlimab administered subcutaneously (sc) to subjects with igan. eligible subjects will have participated in trials 417-201-00007 or vis649-201 and, in the investigator's judgement, could benefit from continued treatment with sibeprenlimab.

Eligibility criteria:
inclusion criteria: * subjects who completed trial 417-201-00007 or vis649-201 without safety concerns and who, in the opinion of the investigator, could potentially benefit from treatment with sibeprenlimab. * egfr ≥ 20 ml/min/1.73 m2, calculated using the chronic kidney disease epidemiology collaboration (ckd-epi) formula. exclusion criteria: * subjects who have not completed participation in trials 417-201-00007 or vis649-201. * subjects who, following enrollment in trials 417-201-00007 or vis649-201 developed a condition or characteristic that would have excluded them from participation in these trials.

Keywords: sibeprenlimab vis649 igan
follow-up of patients with implantable cardioverter defibrillators by home monitoring (anvite)

Conditions: Cardiac Pacing; Electric Countershock; Ventricular Tachyarrhythmia

Summary: patients with implantable cardioverter defibrillators (icds) should undergo regular device follow-ups every 3 months, to verify proper icd function. however, many follow-ups are uneventful, revealing no relevant changes related to the implanted device and in the patient's diagnostic and therapeutic status. for time and economic reasons, longer follow-up intervals are frequently used although they are not according to recommendations. this may increase the delay in detection of relevant changes in the disease and in deviations from optimal icd therapy in the individual patients. in the newest icds, the essential parameters reflecting safety and appropriateness of icd therapy (threshold, impedance, intracardiac electrogram, etc.) are transmitted via home monitoring on a daily basis, to an internet platform accessible by the attending physician. in the present study, the investigators evaluate safety and efficacy of 12-month follow-up intervals in icds with home monitoring capability, as compared with conventional 3-month follow-up scheme.


Eligibility criteria:
inclusion criteria: * indication for a single-chamber implantable cardioverter-defibrillator (icd) exclusion criteria: * contraindication for icd * indication for dual-chamber icd or cardiac resynchronization therapy

Keywords: implantable cardioverter defibrillator remote monitoring follow-up
ticagrelor cytosorb hemoadsorption

Conditions: Emergent Cardiothoracic Surgery; Bleeding; Drug Removal

Summary: tisorb is a study to show that the cytosorb device removes ticagrelor from blood during surgery in patients who need emergency surgery on their heart. the hypothesis of tisorb is that removal of ticagrelor by the cytosorb device during surgery will decrease the risk for surgical bleeding from ticagrelor.


Eligibility criteria:
inclusion criteria: cardiothoracic surgery requiring cardiopulmonary bypass ≤ 48 hours following the last dose of ticagrelor. exclusion criteria: any cardiothoracic surgery \> 48 hours after last dose of ticagrelor.
a study to evaluate inca033989 administered as a monotherapy or in combination with ruxolitinib in participants with myeloproliferative neoplasms

Conditions: Myeloproliferative Neoplasms

Summary: this study is being conducted to evaluate the safety, tolerability, and dose-limiting toxicity (dlt) and determine the maximum tolerated dose (mtd) and/or recommended dose(s) for expansion (rde) of inca033989 administered as a monotherapy or in combination with ruxolitinib in participants with myeloproliferative neoplasms.


Eligibility criteria:
inclusion criteria: * life expectancy \> 6 months. * willingness to undergo a pretreatment and regular on-study bm biopsies and aspirates (as appropriate to disease). * existing documentation from a qualified local laboratory of calr exon-9 mutation. * participants with mf and et as defined in the protocol. exclusion criteria: * presence of any hematological malignancy other than et, pmf, or post-et mf. * active invasive malignancy over the previous 2 years. * active hbv/hcv, hiv. * history of clinically significant or uncontrolled cardiac disease. * has undergone any prior allogenic or autologous stem-cell transplantation or such transplantation is planned. * laboratory values outside the protocol-defined ranges. * participants undergoing treatment with g-csf, gm-csf, or tpo-r agonists at any time within 4 weeks before the first dose of study treatment. * prior history of major bleeding, or thrombosis within the last 3 months prior to study enrollment. * any prior chemotherapy, immunomodulatory drug therapy, immunosuppressive therapy, biological therapy, endocrine therapy, targeted therapy, antibody, or hypomethylating agent used to treat the participant's disease within 5 half-lives or 28 days (whichever is shorter) before the first dose of study treatment. * for tgbs only: undergoing treatment with a potent/strong inhibitor or inducer of cyp 3a4/5 within 14 days or 5 half-lives (whichever is longer) before the first dose of study treatment, or expected to receive such treatment during the study. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: myeloproliferative neoplasms ruxolitinib myelofibrosis essential thrombocythemia calr mutation